Genexiban

DVT & pulmonary embolism (PE). Prevention of VTE in adults who have undergone elective hip or knee replacement surgery; stroke & systemic embolism in patients w/ non-valvular atrial fibrillation (NVAF); recurrent DVT & PE.

DVT & PE 10 mg bid for 1st 7 days followed by 5 mg bid. Prevention of stroke & systemic embolism in patient w/ NVAF 5 mg bid. Patient w/ at least 2 of the following characteristics: Age ≥80 yr, ≤60 kg or serum creatinine ≥1.5 mg/dL Dose may be reduced to 2.5 mg bid. Prevention of VTE 2.5 mg bid. Initial dose should be taken 12-24 hr post-op. Recommended duration of treatment: Hip replacement surgery 32-38 days. Knee replacement surgery 10-14 days. Prevention of recurrent DVT & PE 2.5 mg bid after at least 6 mth of treatment for DVT or PE. Surgery & invasive procedures Patient not previously treated w/ anticoagulants 5 doses of apixaban 5 mg bid (or 2.5 mg bid in patients who qualify for a dose reduction) prior to cardioversion. If cardioversion is required prior to 5 doses of apixaban: give 10 mg loading dose, followed by 5 mg bid. Reduce to 5 mg loading dose followed by 2.5 mg bid if patient meets the criteria for dose reduction. Loading dose should be given at least 2 hr prior to cardioversion.

May be taken with or without food: For patients w/ difficulty swallowing, tab may be crushed & suspended in water/D5W/apple juice or mixed w/ applesauce & promptly administer. Alternatively, crush & suspend in 60 mL water or D5W & administer via nasogastric tube.

Hypersensitivity. Clinically significant active bleeding. Lesion or condition considered a significant risk factor for major bleeding eg, current or recent GI ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophth surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities. Concomitant use w/ any other anticoagulants eg, unfractionated heparin, LMWH (eg, enoxaparin, dalteparin), heparin derivatives (eg, fondaparinux), oral anticoagulants (warfarin, rivaroxaban, dabigatran). Hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk.

Discontinue in patients w/ active pathological hemorrhage. Discontinue use at least 48 hr prior to elective surgery or invasive procedures w/ moderate or high risk of bleeding; at least 24 hr prior to elective surgery or invasive procedures w/ low risk of bleeding. Increased risk of thrombotic events after premature discontinuation; bleeding & can cause serious, potentially fatal, bleeding. Not recommended in patients w/ prosthetic heart valves; undergoing hip fracture surgery; triple-positive antiphospholipid syndrome. Not recommended as an alternative to unfractionated heparin for the initial treatment of patients w/ PE who present w/ hemodynamic instability or who may receive thrombolysis of pulmonary embolectomy. Concomitant use of drugs affecting hemostasis (eg, aspirin & other antiplatelets, other anticoagulants, heparin, thrombolytic agents, SSRIs or SNRIs, NSAIDs); strong inhibitors CYP3A4 & P-gp. Co-administration w/ CYP3A4 & P-gp inducers increase risk of stroke & other thromboembolic events. Risk of developing spinal or epidural hematoma during spinal/epidural anesth or puncture. Indwelling epidural or intrathecal catheters should not be removed w/in 24 hr of the last apixaban dose. The next apixaban dose should not be given earlier than 5 hr after catheter removal. Monitor for signs & symptoms of neurological impairment when neuraxial anesth is employed. Not recommended in patients w/ CrCl <15 mL/min or undergoing dialysis; severe hepatic impairment. Mild or moderate (Child-Pugh A or B) hepatic impairment. Not recommended during pregnancy. Lactation. Childn <18 yr.

Nausea, anemia (post-op & hemorrhagic anemia), contusion, hemorrhage (hematoma, & vag & urethral hemorrhage), postprocedural hemorrhage (postprocedural & vessel puncture-site hematoma, wound & catheter-site hemorrhage), increased transaminases (increased & abnormal ALT), increased AST, increased γ-glutamyltransferase; epistaxis, hematuria, menorrhagia, hemoptysis, rectal hemorrhage, gingival bleeding.

Increased exposure of CYP3A4 & P-gp inhibitors. Decreased exposure of CYP3A4 & P-gp inducers; combined P-gp & strong CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, St. John's wort). Concomitant use w/ combined P-gp & strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir). Increased risk of bleeding w/ antiplatelet agents, fibrinolytics, heparin, aspirin, & chronic NSAID use. Increased mean AUC & C_max w/ naproxen.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

B01AF02 - apixaban ; Belongs to the class of direct factor Xa inhibitors. Used in the treatment of thrombosis.

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